Last updated: November 28, 2023
Sponsor: Mabscale, LLC
Overall Status: Active - Recruiting
Phase
3
Condition
Rosacea
Psoriasis And Psoriatic Disorders
Warts
Treatment
Adalimumab
Humira
Clinical Study ID
NCT06005532
MABPS-3/2020
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent.
- Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
- Established clinical diagnosis plaque psoriasis, lasting at least 6 months before thescreening.
- Plaque psoriasis of moderate or severe severity of stable course with:
- PASI ≥ 12 points;
- BSA ≥ 10 %;
- sPGA ≥ 3 points.
- Patients who have been shown to undergo systemic therapy and/or patients who have hadinsufficient therapeutic efficacy of at least 1 previous standard systemic therapy forpsoriasis, including phototherapy, therapy with cytostatic and immunosuppressivedrugs, or who have had intolerance to standard systemic therapy.
Exclusion
Exclusion Criteria:
- Data on intolerance or hypersensitivity to any components of the drugs, or to anyother human proteins, immunoglobulin preparations.
- A history of severe hypersensitivity reactions of any etiology.
- Other (other than plaque) forms of psoriasis.
- Drug-induced psoriasis.
- Data on the use of the Adalimumab or any preparations of monoclonal antibodiesinhibiting TNF-α at any time during life.
- The presence of Adalimumab antibodies.
- Extensive surgical intervention performed less than 30 days before the screeningperiod, or planned extensive surgical intervention during the study period.
- Active or latent tuberculosis
- Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or ahistory of multiple myeloma.
- Any other malignant neoplasms currently or in anamnesis within the last 5 years, withthe exception of completely removed and/or cured.
- Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to thescreening period.
- Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C,HIV.
- Vaccination with live or attenuated vaccines within 8 weeks before the screeningperiod.
- Hepatic and/or renal insufficiency.
- Pregnancy or lactation.
Study Design
Total Participants: 494
Treatment Group(s): 2
Primary Treatment: Adalimumab
Phase: 3
Study Start date:
October 02, 2023
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Regional dermatovenerologic dispensary
Barnaul,
Russian FederationActive - Recruiting
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
Chelyabinsk,
Russian FederationActive - Recruiting
Interregional Clinical Diagnostic Center
Kazan',
Russian FederationSite Not Available
City clinical hospital n.a.Botkin
Moscow,
Russian FederationSite Not Available
Rheumatology research Instititue n.a.Nasonova
Moscow,
Russian FederationSite Not Available
State Scientific Center of Dermatovenerology and Cosmetology
Nizhny Novgorod,
Russian FederationSite Not Available
Reafan
Novosibirsk,
Russian FederationSite Not Available
New Clinic
Pyatigorsk,
Russian FederationSite Not Available
Dermatovenerologic dispensary N10
Saint Petersburg,
Russian FederationSite Not Available
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